Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K111752 |
Device Name |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
Applicant |
SHANDONG JIANHONG NEW MATERIAL COMPANY |
ROOM 1606 BLDG, 1 JIAN XIANG |
YUAN NO.209 BEI SI |
HUAN ZHONG RD, BEIJING,
CN
10083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
SHANDONG JIANHONG NEW MATERIAL COMPANY |
ROOM 1606 BLDG, 1 JIAN XIANG |
YUAN NO.209 BEI SI |
HUAN ZHONG RD, BEIJING,
CN
10083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/22/2011 |
Decision Date | 07/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|